Abdominal tuina on metabolic sydrome patients with heat stagnation of liver and stomach sydrome: a randomized controlled trial

Phase 1

• Conditions: Metabolic syndrome

• Registration Number: ITMCTR2200005762
• Lead Sponsor: Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1)Aged 18 to 65 years (including borders), no gender limitation.
(2)Participants who meet the metabolic syndrome diagnostic criteria identified by International Diabetes Federation.
(3)Traditional Chinese medicine syndrome was heat stagnation of liver and stomach
(4)Participants have fasting blood glucose between 5.6 and 7.0 mmol/L, and/or 2h post-load glucose level less than 11.1 mmol/L. And no antidiabetic drugs are used to control the blood glucose level at present.
(5)Participants have triglyceride between 1.7 and 5.6 mmol/L,high density lipoprotein cholesterol less than 1.03 mmol/L (male) and 1.29 mmol/L (female), total cholesterol less than 6.2 mmol/L and low density lipoprotein cholesterol less than 4.1 mmol/L. And no lipid-regulating drugs are used to control the blood lipid level at present.
(6)The blood pressure range of the participants are 140-159/90-99 mmHg, cardiovascular risk level stratified into low-risk, and no antihypertensive drugs are used to control the blood pressure at present.
(7)Sign the informed consent by the participants.

Exclusion Criteria

(1)Other primary diseases including chronic kidney disease, chronic liver disease and hypothyroidism lead to abnormalities in blood glucose, blood lipids and blood pressure.
(2)Combined with severe cardiovascular and cerebrovascular diseases, such as heart failure, severe hypertension, cerebral hemorrhage, etc.
(3)Combined with severe liver dysfunction (ALT or AST more than 3 times the upper limit of normal value), malignant tumors and autoimmune diseases.
(4)Pregnancy, preparing for pregnancy or breastfeeding women.
(5)Allergic constitution.
(6)Those who are participating in other clinical trials or have participated in other drug clinical trials within one month after the end.
(7)The researcher judges that it is not suitable to enter the research due to other reasons.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Abdominal circumference;

Secondary Outcome Measures

Name	Time	Method
2 hours postprandial blood glucose;ApoA1;ApoB;Lp(a);Clinic diastolic blood pressure;HDL-C;Fasting blood glucose;HOMA-IR;TCM Evidence Score;N-HDL-C;TG;Clinic systolic blood pressure;CRP;IL-18;leptin;adiponectin;TNF-a;Fasting serum insulin;omentin;TC;IL-1ß;chemerin;LDL-C;Mean arterial pressure;